Clinical Trials Manager- Neurology

Mount Sinai Health System•New York, NY

About The Position

The Neurology department is seeking a Clinical Research Project Manager for the PCORI-funded Treatment with Endovascular Intervention for STroke Patients with Existing Disability (TESTED) clinical trial. TESTED is a comparative effectiveness, observational, multicenter study evaluating endovascular acute stroke treatment among patients with pre-existing disability. The study aims to address disparities in care for acute ischemic stroke. As the prime project manager, the successful candidate will oversee national project management and work directly with clinical trial performance sites. The role requires a clinical background and extensive clinical research experience. The manager will lead the clinical project team, coordinate study activities and communications, support grant management and regulatory compliance, and work with the study team and sites to achieve clinical study goals.

Requirements

Bachelor's degree in Nursing, Biology, Public Health, or a related scientific or health field.
At least 6 years of experience managing clinical trials, including 2 years in a management or leadership role.
Excellent communication skills for conveying information to study-team members and external contacts, including vendors and consultants.
Problem-solving, organizational, and leadership skills.
Ability to work with little or no supervision.
Strong attention to detail.
Ability to meet deadlines while managing multiple responsibilities or projects.
Ability to work as part of a team and, when needed, lead a team.
Strong work ethic and self-discipline.
Ability to organize and motivate study-team members.
Proficiency with basic computer applications used in daily project operations.

Nice To Haves

Master's degree.
Experience writing clinical study procedures and other clinical documents.
Experience in an academic or clinical setting in the area of clinical specialization.
SoCRA and/or ACRP certification.

Responsibilities

Develop and manage changes to the protocol, ICD, MOP, CRFs, and study tools.
Plan investigator meetings.
Help lead monthly webinars and prepare presentation slides.
Develop and circulate a monthly newsletter.
Develop and track training for sites.
Lead and maintain study-wide communications.
Analyze screen-failure data.
Develop recruitment materials, including a brochure and video.
Conduct and schedule site-readiness calls.
Participate in grant management, including oversight of overall grant finances.
Submit biannual reports to PCORI.
Answer clinical and protocol questions.
Ensure protocol compliance and work collaboratively with team members to ensure regulatory compliance.
Maintain ClinicalTrials.gov information.
Develop strategies to promote study enthusiasm and site engagement.
Communicate key study updates to sites through webinars and other channels.
Maintain communication with PCORI.
Lead the clinical project team and various study-team meetings.
Help resolve issues and participate in process-improvement initiatives.
Work with study-team members to outline priorities and resolve project conflicts.
Manage documents related to the clinical study with the study team.
Maintain protocol versions and the trial's manual of procedures.
Help prepare safety reports in collaboration with project clinical leaders and sites.
Perform related duties based on departmental need.